CQV Engineer / Qualification & Validation Engineer 80-100% (m/f/d)
Core
Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems, and support post-implementation SLC in a GMP environment.
Role type
CQV Engineer (Commissioning, Qualification, and Validation)
Builds
Qualification and validation of process engineering equipment and facilities
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP compliance, commissioning, qualification, validation, deviation management, CAPA implementation, change management, coordination with external providers
Preferred skills
COMOS, DMS, Kneat, TrackWise, SAP, MS Office
Responsibilities
Develop and maintain commissioning and qualification documents; Supervise and resolve deviations; Manage changes (GEP and GMP); Implement CAPAs; Coordinate with internal teams and external service providers; Present qualification documents during audits and inspections
Seniority
Mid-level, hands-on IC
